New Delhi: Four more medical devices — nebulisers, glucometers, digital thermometers and blood pressure monitors — have been notified in the latest addition to product categories under the Drugs and Cosmetics Act, which will ensure their quality and performance.

This means such devices will be under regulation and their import, manufacture and sale will be under scrutiny. Twenty-seven product categories are now notified under the Act, said an official from the Ministry of Health and Family Welfare (MoHFW). The categories which are not notified for regulation are sold in the open market without adequate checks and balances, including for instance, pacemakers. “We are moving in the direction to now regulate all implantable devices,” said S Eswara Reddy, Drug Controller General of India (DCGI). Read the rest of this entry »

New Delhi: The Health Ministry has made it mandatory for foreign nationals seeking organ transplant in India to be registered in the waiting list of hospitals following reports claiming they were being given preferential treatment by some private institutions.

The registered transplant centre has to intimate the Regional Organ and Tissue Transplant Organisations (ROTTOs) and the list of foreign nationals seeking organ donation in India has to be shared with the NOTTO (National Organ and Tissue Transplant Organisation) in advance, officials said here.

Also, an organ can be allotted to a foreign national only if there is no Indian recipient available to receive the donated organ at that time, said Dr Vasanthi Ramesh, Director of NOTTO.

New Delhi: Homeopathy doctors will soon be barred from selling medicines from the premises they are practising in, according to new rules proposed by the government that are to be notified soon.

“No registered homeopathic medical practitioner who is practicing homeopathy in the premises where homeopathy medicines are sold, shall deal in homeopathic medicines,” according to the new draft rules.The new rules were drafted following complaints that commercial interests were influencing the behaviour of homeopaths, two government officials privy to the development said.

“It was seen that various pharmacists had started to station a homeopath in their shop for consultations. Likewise, homeopathy practitioners other than dispensing their medicines to their patients had started selling them over the counter too. For better regulation of homeopathic medicines, this practice needed to end,” said one of the two officials cited above.

“Once notified, this will delink consultation and selling of medicines. Chemist shop is a commercial entity and the objective of this rule is to ensure that doctors only prescribe and not sell medicines,” said the official cited above, requesting anonymity.

Homeopath Kalyan Banerjee said that the new draft rules will come as a setback to doctors selling drugs.

“This will create a lot of problems for those doctors who sell medicines over the counter too,” Banerjee said.According to one of the draft rules, chemists selling allopathic medicines will also be allowed to sell homeopathic medicines without the need to have a separate licence, as required now.

“These medicines shall be sold in the original sealed small quantity packing and they will have to be stored separately from allopathic drugs,” said the second of the two health ministry officials cited earlier.

The proposed rules also aim to weed out unqualified people from dispensing homeopathic medicines.

A person eligible to practice medicine with prescriptive rights should hold a degree in homeopathy from a recognized university or a degree in pharmacy from a recognized university or a bachelor’s degree with one year of experience in dealing with homeopathic medicines in the clinic of a registered homeopathic medical practitioner or with the holder of a licence in Form 20C or Form 20D (applications for retail are made under these forms) or diploma in homeopathic pharmacy or diploma in homeopathy and surgery.

R.K. Manchanda, co-chair of a sub-committee of the Drug Technical Advisory Board (DTAB) and the Director General of Central Council of Homeopathy (CCH), said the new rules will help promote quality homeopathic medicines.

“The competent authorities have been defined in the new rules for dispensing homeopathic drugs, thereby preventing a host of complications caused by wrong dispensing. The homeopathic medicines will be available widespread in chemists shops as there will be no need to have an additional licence to keep homeopathic medicines as required as per the existing rules. Once the new rules come into effect, the homeopathic medicines will be readily available even in far-flung areas.”

Homoeopathic medicines are covered under the provisions of Drugs and Cosmetic Act, 1940.

The new draft rules which were discussed in detail by the sub committee of DTAB before they were sent to law ministry for vetting will be notified by the ministry of health and family welfare.

To promote homeopathy, the new rules also do away with the need for a licence for exhibiting homeopathic drugs for promotional activities in any fair.

The manufacturers will also have to adhere to requirements of Good Manufacturing Practices (GMP) for obtaining a licence for manufacturing, which will remain valid for five years.

NEW DELHI: Healthcare Global Enterprises (HCG), a Bengaluru-based chain of specialised cancer care centres, plans to set up a dozen new hospitals over the next 18 months, the publicly traded company’s chairman, BS Ajai Kumar, said.

HCG plans to expand its network of cancer care centres to about 30 from 21 now, and will add a few more IVF clinics to its existing network, Kumar told ET.

HCG has a partnership with Kamini Rao, a leading medical practitioner in the field of assisted reproduction, to run IVF clinics under the brand name ‘Milann’. Read the rest of this entry »

New Delhi: In a bid to revive India’s active pharmaceutical ingredient (API) and bulk drug market, the government is contemplating restrictions on the import of APIs and has suggested setting up of mega bulk drug parks, a move that is expected to boost domestic production.

In the draft pharmaceutical policy framed by the department of pharmaceuticals under the ministry of chemicals and fertilizers, the centre has proposed “peak customs duty” for all APIs that can be indigenously manufactured.

Bulk drugs or APIs are the active raw materials used in a drug that give it the therapeutic effect. “All APIs which can be indigenously manufactured should be imported at peak customs duty,” said the draft policy, reviewed by Mint.

New Delhi: International healthcare firm Columbia Asia will invest over Rs 400 crore to set up two new hospitals in India by the end of 2019 as it looks to expand presence in the country. The chain currently has 11 multi-speciality hospitals in India with over 1,000 beds in cities such as Bengaluru, Kolkata, Ahmedabad, Mysuru, Gurugram, Ghaziabad, Patiala, and Pune. “We are planning to open two hospitals in the country by the end of 2019. The investment on this will be over Rs 400 crore”, Columbia Asia India Chairman, CEO and GMD Nandakumar Jairam told PTI. The new hospitals will be located in Bengaluru and Pune, he added. “With the opening of

NEW DELHI: India’s drug regulator has eased licencing norms for vaccine and recombinant-DNA manufacturers in a move expected to promote research and development of new drugs in the country.

The Central Drugs Standard Control Organisation (CDSCO) has done away with the need for joint inspections to issue licences to allow such companies to make biologic products for testing and analysis purposes. The regulator has also clarified that these biologics can also be exported only for the purpose of examination, test or analysis and not for commercial purposes in a circular dated December 13.

According to CDSCO’s latest decision, State Licencing Authorities will issue ‘Form 29’ licences to vaccine and r-DNA makers within three working days of them submitting their application. The joint inspection of these applicants will now be carried out using a risk-based approach only after the licence is issued.

Form 29 licences are issued to allow companies to manufacture biological products for examination, testing or analytical purposes.